Orthotopic artificial bladder endoprosthesis

Abstract

An orthotopic artificial bladder endoprosthesis includes a first portion connectable to a urethra of a patient and a second portion connectable to the ureters of the patient; the first portion including a collapsible cover made of a multi-layered silicone membrane having an external surface and an internal surface both coated with pyrolytic turbostratic carbon; the second portion including a resorbable cap including a fabric of PGA fibers and a frame, coupled with the cap, made using PGA/PLA copolymer; the cover and the cap being connected together along their respective edges, to define an enclosure.

The invention claimed is: 
     
       1. An orthotopic artificial bladder endoprosthesis comprising:
 a first portion connectable to a urethra of a patient and a second portion connectable to ureters of said patient; 
 said first portion comprising a collapsible cover made of a multi-layered silicone membrane having an external surface and an internal surface both coated with pyrolytic turbostratic carbon; 
 said second portion comprising a resorbable cap comprising a fabric of PGA fibres and a frame, coupled with said cap, made using a PGA/PLA copolymer; said cover and said cap being connected together along respective edges of the cover and of the cap, to define an enclosure between the cover and the cap, the frame comprising a plurality of spaced apart arms, fixed to a joining portion to extend from the joining portion in a star configuration, and defining a dome profile, wherein the frame is disposed over only a portion of the cap such that the fabric of the cap is exposed at each space between adjacent arms of the frame. 
 
     
     
       2. The endoprosthesis according to  claim 1 , wherein the cover comprises a strip protruding from said edge of the cover and made of a biocompatible and non-resorbable material; said strip being fixed to said edge of said cap. 
     
     
       3. The endoprosthesis according to  claim 2 , wherein said strip is formed by a matrix made of polyethylene terephthalate and/or stretched expanded polytetrafluoroethylene. 
     
     
       4. The endoprosthesis according to  claim 2 , wherein said strip is disposed between two layers located near the respective edge of the cover. 
     
     
       5. The endoprosthesis according to  claim 2 , wherein said strip extends along the entire edge of the cover. 
     
     
       6. The endoprosthesis according to  claim 1 , wherein the fabric of said cap is a warp knitted fabric. 
     
     
       7. The endoprosthesis according to  claim 1 , wherein the copolymer PGA/PLA comprises 30% PGA and 70% PLA. 
     
     
       8. The endoprosthesis according to  claim 1 , wherein said first portion comprises a connection body connected to the cover to connect said cover to the urethra, said connection body having a substantially funnel shape. 
     
     
       9. The endoprosthesis according to  claim 1 , wherein the membrane of said cover is between 500 μm and 700 μm thick. 
     
     
       10. The endoprosthesis according to  claim 1 , wherein the fabric of said cap is a textured fabric. 
     
     
       11. The endoprosthesis according to  claim 1 , wherein the membrane of said cover is 600 μm thick. 
     
     
       12. An orthotopic artificial bladder endoprosthesis device, comprising:
 a first portion connectable to a urethra of a patient, the first portion comprising a collapsible cover made of a multi-layered silicone membrane having an external surface and an internal surface both coated with pyrolytic turbostratic carbon; and 
 a second portion connectable to ureters of said patient, the second portion comprising:
 a resorbable cap comprising a fabric of PGA fibres; and 
 a frame connected to the fabric of the cap, the frame comprising a plurality of spaced apart curved arms arranged in a star configuration and defining a dome profile, the arms are fixed together at a joining portion of the frame to extend from the joining portion, the frame being made using a PGA/PLA copolymer; and 
 
 an edge of the cover and an edge of the cap connected at an edge connection to form an enclosure between the cover and the cap, the edge connection comprising a strip of material protruding from the edge of the cover and embedded between two adjacent silicone layers of the membrane, thereby providing a protruding edge of the cover at which the cap is connected; 
 wherein the fabric of the resorbable cap is connected to the frame to assume the dome profile of the frame, and 
 wherein the fabric of the resorbable cap is supported by the frame. 
 
     
     
       13. The device according to  claim 12 , wherein the frame is fixed to the fabric of the cap by one or more resorbable devices. 
     
     
       14. The device according to  claim 12 , wherein the one or more resorbable devices is resorbable sutures. 
     
     
       15. The device according to  claim 12 , wherein the dome profile of the frame is imparted when hot by thermoforming. 
     
     
       16. The device according to  claim 12 , wherein the frame is located outside of the cap.